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Robotics for Mobility Rehabilitation in MS

NCT05102682 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2024-02-22

No results posted yet for this study

Summary

Title Prospective, open label, single arm, non-randomized, non-comparative feasibility study of Rex robot assisted rehabilitation exercise to enhance balance, mobility and upper limb function in people with Multiple Sclerosis "RAPPER III - MS Objective The objective of this study is to evaluate the feasibility and safety of the REX Robot when used for rehabilitation with people who have moderate to severe mobility restrictions due to MS. A secondary objective of the study is to explore the acceptability of the device to people with MS and its impact on impairments and functions commonly affected by MS.

Study Sponsor Rex Bionics, Plc. Study Device REX Robotic powered exercise system Primary Endpoint • Completion of a transfer, stand, balance and walk rehabilitation session.

* Unexpected Serious Adverse Events Secondary Endpoints
* Completion of a transfer, stand, balance and walk rehabilitation program over Six-weeks
* The Number of approached, screened, and eligible potential participants. Reasons for Ineligibility. (See 'RAPPER III- MS 007 Screening Loss Analysis REV 0 FINAL')
* Functional Ambulation Classification (FAC) 1
* Activities-specific Balance Confidence (ABC) Scale 2
* Modified Falls Efficacy Scale (MFES) 3, 4,
* Multiple Sclerosis Walking scale (MSWS-12) 5
* Multiple Sclerosis Impact scale (MSIS-29) 6
* ARMA (arm activity measure) 7
* Berg Balance Scale 8
* Timed unsupported steady stand (TUSS) 9
* Pain scale questionnaire (Visual Analog Score VAS) 10
* Modified Ashworth Score 11
* Spasticity Impact Scale 12
* Epworth Sleepiness Scale (ESS) questionnaire 13
* EQ-5D Health State Questionnaire 14

Questionnaires may be administered in person, by phone, email or in the post.

Conditions

Interventions

OTHER

Balance exercise program using exoskeleton device

Exercise program focused on strengthening core body muscles and balance supported by Rex exoskeleton device

Sponsors & Collaborators

  • East Kent Hospitals University NHS Foundation Trust

    lead OTHER_GOV

Principal Investigators

  • Mohamed Dr Sakel, MBBS · East Kent Hospitals University NHS Foundation Trust

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-10
Primary Completion
2017-09-12
Completion
2017-09-12

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05102682 on ClinicalTrials.gov